|Year : 2021 | Volume
| Issue : 1 | Page : 33-38
Pharmaceutical validation of modified Chitraka Haritaki Avaleha: An ayurveda semisolid dosage form
Sonam Sagar Bhinde1, Sagar Mahendrabhai Bhinde2, Virendrakumar K Kori2, Swapnil Y Chaudhari1, Biswajyoti J Patagiri1, Kalpna S Patel2
1 Department of Rasa Shastra and Bhaishjya Kalpana Including Drug Research, IPGT & RA, Jamnagar, Gujarat, India
2 Kaumarbhritya, IPGT & RA, Jamnagar, Gujarat, India
|Date of Submission||26-Nov-2020|
|Date of Decision||04-Dec-2020|
|Date of Acceptance||12-Dec-2020|
|Date of Web Publication||16-Apr-2021|
Dr. Sonam Sagar Bhinde
Department of Rasa Shastra and Bhaishjya Kalpana Including Drug Research, IPGT & RA, Jamnagar, Gujarat.
Source of Support: None, Conflict of Interest: None
Introduction: Chitraka Haritaki Avaleha (CHA) is a well-known Ayurveda preparation recommended in the management of chronic rhinitis, cough, asthma, anorexia, pthisis, and worm infestation. These diseases are more common in children, and, hence, CHA is one of the important formulations used in pediatric patients. However, considering its nonpalatable (bitter astringent) taste along with complexity of confection preparation, it is high time to amend and validate its pharmaceutical process. Aim: To prepare modified CHA and develop standard manufacturing procedures for this modified formulation. Materials and Methods: Five pilot batches with varying proportions of ingredients were prepared to fix the ratio of formulation composition and to make it palatable for children. In these five pilot batches, the proportion of the fifth batch was found to be most acceptable and, hence, the ratio of this batch was kept as a standard formulation based on organoleptic parameters; this procedure was repeated thrice to ensure the process validation. Results: Preparation of confection by the classical method by adding Terminalia chebula Retz. powder in decoction was not palatable for pediatric purpose. Jaggery was increased by 1.5 times, Terminalia chebula Retz. powder was reduced by 50%, and Terminalia chebula Retz. was added. Jaggery (1.5 times) used in condiments gave a desired palatable taste (mild bitter and mild astringent) for children. Conclusion: This modified process can be considered as a standard manufacturing process of CHA, especially for pediatric use.
Keywords: Avaleha, Chitraka Haritaki Avaleha, dosage form modification, Guda Paka, pediatric use, process validation
|How to cite this article:|
Bhinde SS, Bhinde SM, Kori VK, Chaudhari SY, Patagiri BJ, Patel KS. Pharmaceutical validation of modified Chitraka Haritaki Avaleha: An ayurveda semisolid dosage form. J Indian Sys Medicine 2021;9:33-8
|How to cite this URL:|
Bhinde SS, Bhinde SM, Kori VK, Chaudhari SY, Patagiri BJ, Patel KS. Pharmaceutical validation of modified Chitraka Haritaki Avaleha: An ayurveda semisolid dosage form. J Indian Sys Medicine [serial online] 2021 [cited 2021 Jul 25];9:33-8. Available from: https://www.joinsysmed.com/text.asp?2021/9/1/33/313695
| Introduction|| |
Classical text books of Ayurveda hold a number of remedies for different pathologies. CHA is one such formulation that has significant therapeutic effects in cases of chronic rhinitis (sinusitis), cough, asthma, digestive impairment, pthisis, and worm infestation.,, Though this classical formulation is clinically effective, it poses certain inconvenience to children because of its classical bitter–astringent taste. To overcome this, there is a need to amend its process in such a way that it becomes acceptable and remains therapeutically viable. It is also an important task to develop an appropriate quality standard for drug preparation, which satisfies the high standards of good manufacturing practices. Looking at the vast variety of references and methods in herbal drug preparation, the World Health Organization has also framed a code of Drug Manufacturing Practice in herbal medicine. As per Ayurvedic Pharmacopeia of India (API), CHA is bitter–astringent in taste; it has Haritaki (Terminalia chebula Retz.) powder in the proportion of 30.17%, which should be added in the decoction and should be cooked till the end of the preparation. Considering its bitter–astringent taste along with complexity in preparation, it is high time to work in this regard. Hence, this study is aimed at preparing palatable CHA and at developing standard manufacturing procedures for this modified CHA.
| Materials and methods|| |
All the herbal raw materials and Yavakshara were procured from the pharmacy, Gujarat Ayurved University, Jamnagar. All the components were separated from physical impurities such as small stones, sand particles. Honey (brand: Indian honey) and jaggery were purchased from Khadigrammodhara, Jamnagar. All the drugs were authenticated in the pharmacognosy Laboratory of the Institute. Formulation composition of CHA as per API is placed in [Table 1]. Equipment used in this process along with their specifications are mentioned in [Table 2].
Pharmaceutical procedure of CHA
Preparation of Powder
All the herbal drugs mentioned for Prakshepa (Cinnamomnm zeylanicum Breyn, Cinnamom umtamala Nees and Eber, Elettaria cardamomum Maton, Zingiber officinale Rosc., Piper nigrum Linn., Piper longum Linn) and Terminalia chebula Retz. were cleaned, powdered individually in a mixer, and sieved through #72 to obtain fine powders. Yavakshara was also ground into fine powder.
Preparation of Decoction
The decoction preparation was done as per the reference of Sharangdhara Samhita. Totally, 5.320 kg coarse powders of each drug (Dashamoola, Plumbago zeylanica Linn., Emblica officinalis Gaertn. and Tinospora cordifolia Mier ex Hook) were taken in equal quantity(1.330 kg) in a stainless steel container of 60 L capacity. Then, 42.56 L (eight times) of potable water was added to it and allowed to soak overnight. On the morning of the next day, the contents were subjected to heat and stirred continuously throughout the process till the volume was reduced to a quarter, that is, 10.64 L. Throughout the procedure of boiling, the temperature was maintained between 85oC and 95oC.
These prepreparations remain the same in all five pilot batches and three main batches.
Preparation of modified CHA
Decoction (10.64 L) and jaggery (4 kg) were mixed in a steel vessel and allowed to dissolve completely. The contents were filtered through cotton cloth to remove the possible impurities of jaggery. It was then subjected to heat (at 95°C to 100°C) for eight hours, until the appearance of confirmatory tests of proper cooking of linctus, such as sticking to ladle, thread-like consistency, and sinking in water. The contents were stirred continuously throughout the process. At the end of this procedure, the contents were removed from the heating source and Terminalia chebula Retz. powder was added slowly with continuous stirring. After self-cooling for some time, condiments were added at a temperature of 55oC. The contents were stirred continuously till the blend became cool, homogenous, and a semisolid mass. The next day at room temperature, honey was added. The finished product was stored in airtight containers [Figure 1].
| Observations and results|| |
An average 57.48% yield of powder of Terminalia chebula Retz. was obtained [Table 3].
The yield after making powder of condiments such as Zingiber officinale Rosc., Piper longum Linn, Piper nigrum Linn., Cinnamomnm zeylanicum Breyn, Elettaria cardamomum Maton, and Cinnamomum tamala Nees & Eber was found to be 74%, 83%, 90%, 88%, 55%, and 63%, respectively [Table 4].
The first pilot batch of CHA was prepared as per the classical method, and it was not palatable in taste. So, step-by-step amendments were done in the next four pilot batches by modification in the method of preparation and in proportion [Table 5].
The organoleptic characters of all pilot batches are given in [Table 6].
The final large three batches were prepared as per the process of pilot batch 5. The average yield of CHA was 5.448 kg [Table 7].
During the procedure of Avaleha, the temperature was maintained between 80°C and 90°C and it was observed as sticking to the ladle; at 90°C, it had a thread-like consistency; at 94°C, it sank in water; and at 95°C, it was stable in water [Table 8].
| Discussion|| |
The average yields of Terminalia chebula Retz. powder from raw Terminalia chebula Retz. fruits, Piper longum Linn, and Zingiber officinale Rosc. were, respectively, 57.48%, 83.0%, and 74.1%. It may be due to the removal of external impurities, and it is fibrous in nature. The yield of fine powder was less, because it was difficult for the ground powder to pass through sieve #72.
In the current study, totally five pilot batches were prepared for fixing a suitable method of preparation, to make CHA palatable for pediatric use. The first pilot batch (CHA p1) was prepared as per classical proportions and methods. In this method, Terminalia chebula Retz. powder was cooked with jaggery. Because of cooking with jaggery, the taste was both bitter and astringent. It may be due to the increased liberation of tannins (which are basically astringent in taste) content of Terminalia chebula Retz. by prolonged heat. It was difficult to consume for pediatric patients. In CHA p2, the proportion of jaggery was increased upto 1.5 times to reduce bitterness and Terminalia chebula Retz. powder was added as per the classical method. Still, the taste remained mild bitter and astringent. This may be due to the unchanged proportion and method of addition of T erminalia chebula Retz. powder. In CHA p3, the proportion of jaggery was increased upto 1.5 times and Terminalia chebula Retz. powder was added as condiments in the ratio mentioned in classical texts; however, the taste remains both mild bitter and astringent. In CHA p4, the proportion of jaggery was increased upto 1.5 times; Terminalia chebula Retz. powder was decreased to 50%; and the method of preparation was maintained the same as in classical texts, but its taste remains both mild bitter and astringent. In CHA p5, the proportion of ingredients was maintained the same as CHA p4; Terminalia chebula Retz. powder was added in condiments instead of cooking with jaggery, and its taste became both mild bitter and mild astringent as compared with previous batches. So the ratio and method of preparation were maintained the same as CHA p5 for further three batches to ensure the process validation.
During the preparation of decoction, characteristic color and smell were noted after one to two hours of heating. Initially, some raw materials were seen floating over the surface, which gradually settled down to the bottom. During the boiling, temperature was maintained between 85oC and 95oC. During this process, the froth started to limit to the edges of the container. Continuous stirring was done for proper extraction and to lessen the possible chances of degradation of some active constituents, which may be decomposed due to hydrolysis. Continuous stirring is also needed to facilitate the natural circulation evaporation. Decoction preparation was done by mixing coarse powder (sieve number 44) of raw material with the addition of eight times of water. An average of 10.5 liters of decoction was prepared from 5.445 kg of decoction powder.
After the mixing of jaggery, the contents became darker. After three to four hours of heating with jaggery, the mixture became thick. A characteristic sweet odor of jaggery was observed during cooking. One thread thickness was observed after six hours of heating, which reached a two-thread consistency after 25 min. The heat was stopped immediately. Sticking to the ladle was noted at 170 min, heat was maintained up to the no-spreading property stage, and a two-thread thickness was noted at this final stage. All the chief desired characteristics of preparation with jaggery were observed well during the confection preparation. As most of the volatile principles of drugs of condiments, they were added in increments at the end of the procedure with constant stirring to get a homogenous blend and to prevent volatilization. Honey was added the next day, having a 37°C temperature of confection. Other characteristics such as stability, imparted fingerprints, and desired color–odor–taste were seen after completion of the process. An average of 5.448 kg confection was made from 10.5 liters of decoction, 3.998 kg of jaggery, and 323 g of condiments.
| Conclusion|| |
The pilot batches reveal that in contrast to classical reference, Terminalia chebula Retz. powder was required to be added as a condiment with half proportion and the proportion of jaggery was required to increase by 1.5 times to make it palatable for pediatric use. This modified proportion of ingredients and pharmaceutical procedure can be considered as a standard for modified CHA. As no standard published data are available about the standard manufacturing process of this formulation, a comparison is not possible and the current findings can be considered as a standard for future studies. This study could be considered the first step toward standardization of this modified CHA through future studies on analytical parameters.
Financial support and sponsorship
IPGT and RA, Gujarat Ayurved University.
Conflicts of interest
There are no conflicts of interest.
| References|| |
Ratnavali B Nasarogadhikara, 63rd chapter, by Kaviraj Govinddassen (with sidhdhiprada Hindi commentary by Prof sidhdhinandan Mishra). Varanasi: Chaukhambha Surbharati Prakashana; 2009. p. 979.
Anonymous. The Ayurvedic Pharmacopia of India, Part 2, Volume 1. 1st ed. New Delhi: Appendices, Ministry of Health and Family Welfare, Department of AYUSH, Government of India; 2008. p. 16.
Chakrapanidutta, Nasarogadhikara 58th chapter, in IndradevaTripathi, Chakradutta, 3rd ed. Varansi: Hindi Commentary, Chaukhambha Sanskrit Series; 1997. p. 346.
Anonymous. Guidelines on Safety Monitoring and Pharmacovigilance on Herbal Medicine. Geneva: World Health Organization; 2003.
Sharangdhara, Kwatha kalpana 9th chapter, in Madhyamakhanda, Sharangdharasamhita (with Dipika and Goodartha Dipika commentary and edited with footnotes by Pandit Parsuram Shastri). Varanasi: Chaukhambha Surbharati Prakashana; 2006. p. 144.
de Hoyos-Martinez P, Merle J, Labidi J, Charrier-El Bouhtoury F Tannins extraction: A key point for their valorization and cleaner production. J Cleaner Product 2019;206:1138-55.
Carter SJ Cooper and Gunn’s Tutorial Pharmacy. 6th ed. New Delhi: CBS Publishers and Distributors; 2004. p. 255.
Mehta RM Pharmaceutics 1. Delhi: Vallabh Prakashana; 2005. p. 174.
[Table 1], [Table 2], [Table 3], [Table 4], [Table 5], [Table 6], [Table 7], [Table 8]